Phase 2 Study of Atorvastatin Safety and Antitumor Effects in Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00185731|
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : December 2, 2017
Last Update Posted : December 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma, Non-Hodgkin||Drug: Atorvastatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Atorvastatin in Patients With Low Grade or Refractory Non-Hodgkin's Lymphoma|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
Experimental: 80 mg Atorvastatin
Atorvastatin, 80 mg tablet, will be taken orally by the patient daily, beginning on study day 1.
80 mg orally once daily
Other Name: Lipitor
- Tumor Apoptosis [ Time Frame: 1 year ]Expressed as the number of participants whose tumor cells showed an increase in apoptosis during atorvastatin treatment
- Correlation of Tumor Apoptosis to Clinical Response [ Time Frame: 1 year ]The validity of tumor apoptosis as a biologic endpoint was assessed by correlation to clinical response. A correlation substantially less than 1 is interpreted as a poor correlation, while a correlation near +1 or -1 is interpreted as a strong correlation.
- Atorvastatin Toxicity [ Time Frame: 1 year ]Assessed as the number of study participants with atorvastatin-related serious adverse events (SAEs).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00185731
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Dean Felsher||Stanford University|